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Phase 1 Study of RO7663498 Eye Injections to Test Safety and Body Response in Adults with Diabetic Retinopathy
Led by Hoffmann-La Roche · Updated on 2026-07-20
30
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, tolerability, and pharmacokinetics of RO7663498 when given as intravitreal injections to adults with diabetic retinopathy. The study is a Phase 1, multicenter, non-randomized, open-label trial sponsored by Hoffmann-La Roche, focusing on participants diagnosed with diabetes mellitus and non-proliferative diabetic retinopathy. Participants will receive multiple ascending doses of RO7663498 through injections into the eye. The study includes several cohorts, each receiving the drug according to the protocol schedule, with no placebo group. The treatment period includes monitoring up to 20 weeks after administration. Throughout the study, participants will undergo ophthalmological assessments, including visual acuity tests and safety monitoring for ocular and systemic adverse events. Researchers will collect aqueous humor and blood samples to measure drug concentrations. The study lasts up to 20 weeks, during which participants will be closely observed for safety and drug effects on the eye.
CONDITIONS
Brief Title
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy
Research Team
R
Reference Study ID Number: BP46156 https://forpatients.roche.com/ No email attachments.
F
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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